Why Are Children Included in Research?

Research is commonly done with adults first and many medicines and treatments have been studied only in adults. You may wonder why children are included in research since it involves uncertainty and may have risks. In many cases, research with children is important because of:

• Developmental Differences: Because children’s bodies and brains are developing differently from adults, children sometimes don’t respond in the same way that adults do. For example, the correct dose of a medicine for a child cannot be decided by simply decreasing the adult dose to match the child’s size. When studies were done on a seizure medicine called Neurontin, it showed that children less than 5 years of age actually needed a larger dose of the medicine to prevent seizures.
• Childhood Conditions: Some problems occur only in children and cannot be tested in adults, like congenital heart defects and prematurity. For children to benefit from new medicines and treatments, it’s important to include them in research studies.
• Side Effects: Side effects of some medicines only happen in children or happen differently in children. For example, Tetracycline is an antibiotic that when given to young children can stain their teeth; giving aspirin to children with viruses is linked to Reye’s syndrome.

Policies to Protect Children

In 1998, the National Institutes of Health (NIH) made a policy that children should be included in all NIH-supported research unless there are good reasons to leave them out. In 2002, Congress approved the Best Pharmaceuticals for Children Act which urges drug companies to do studies of certain medicines that are used in children but have not yet been studied in children.